The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Voyant Open Fusion Device.
| Device ID | K153288 |
| 510k Number | K153288 |
| Device Name: | Voyant Open Fusion Device |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | APPLIED MEDICAL RESOURCES 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Contact | Jessica Cho |
| Correspondent | Jessica Cho APPLIED MEDICAL RESOURCES 22872 Avenida Empresa Rancho Santa Margarita, CA 92688 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-13 |
| Decision Date | 2016-06-01 |
| Summary: | summary |